Efficacy of DBM Fasciatherapy for Patients Suffering From Chronic Low Back Pain

Low Back Pain Clinical Trial

Official title:

Interest of DBM Fasciatherapy for Physiotherapy in the Care of Patients Suffering From Non-Specific Chronic Low Back Pain: a Cluster Randomized Multicenter Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04812678
• Other study ID #: FF2021
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: September 6, 2023

Study information

• Verified date: September 2023
• Source: FasciaFrance
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Low back pain (LBP) is pain localized below the costal margin and above the inferior gluteal folds. It may be associated with radiculalgia. Non-specific LBP refers to LBP without specific problems such as infection, inflammation, vertebral fracture or cancer. Chronic LBP is a LBP lasting more than 3 months.

The causes of LBP remain unknown. While there are recommendations for physiotherapy, the protocol of care is not well defined. New therapeutic models centered on neurophysiology are replacing biomechanics-based models. New programs centered on patient education and a biopsychosocial approach are emerging.

Research has shown the possible involvement of fascia in LBP and the interest of manual fascia therapies in the treatment of LBP. To date, there are no studies that have shown the effects of fasciatherapy in the treatment of non-specific LBP.

In France, many physiotherapists use this type of treatment and more specifically fasciatherapy. French physiotherapists say that it may improve their management of LBP. Studies on fasciatherapy have highlighted the effects of fasciatherapy in the management of fibromyalgia pain, the treatment of anxiety, malaise and the improvement of body perception. They show the multidimensional actions of fasciatherapy and support its clinical, functional and psychosocial evaluation for LBP.

Fasciatherapy is part of the manual therapies that target their action on the fascial system. This "patient-centered" technique is a biopsychosocial and humanistic approach to health. The manual and gestural approaches of the fascia are part of the Non-Pharmaceutical Interventions field. Fasciatherapy involves manual and gestural interventions, with the objective of restoring the contractile, elastic and movement properties of the fascia in order to provide relief, improve function and quality of life for patients.

In France, fasciatherapy is not part of recommendations and is not recognized by the Conseil National de l'Ordre des Masseurs-Kinésithérapeutes.

This study aims to assess the effects of fasciatherapy on LBP and to evaluate how it could contribute to its management for physiotherapists. It is a cluster randomized trial conducted on 180 subjects. Intensity of pain (measured with VAS) is the primary outcome. The secondary outcomes are the impact of LBP on daily life (Dallas Pain Questionnaire), on quality of life (SF-12 questionnaire), on anxiety (STAI questionnaire), and the evolution of drug consumption.

The study will take place in France and the treatment structures will be the practitioners' practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: September 6, 2023
• Est. primary completion date: September 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• First consultation for Low Back Pain with the practitioner

• Having a diagnostic of chronic non-specific Low Back Pain based on the French Haute Autorité de Santé guidelines (https://www.has-sante.fr/upload/docs/application/pdf/2019-04/fm_lombalgie_v2_2.pdf):

• excluding specific Low Back Pain (tumor, infection, inflammation, etc.)

• no red flag

• Low Back Pain for more than 3 months

• Having had the French validated version of:

• evaluation of pain intensity with Visual Analog Scale

• STarT Back Screening Tool questionnaire

• Dallas Pain questionnaire

Exclusion Criteria:

• Specific Low Back Pain (rheumatologist disease, tumoral compression, central neurological pathology, etc.)

• Psychiatric disorder (apart from the usual co-morbidities of chronic low back pain)

• Pregnancy or breastfeeding

• Being under guardianship or curatorship

• Deprivation of liberty or legal protection measure

• Being unable to give consent

• Being unable of fill out a questionnaire

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Procedure:
• Fasciatherapy
Fasciatherapy, with manual therapy and/or gestual therapy.
• Physiotherapy
Conventional physiotherapy with massage, exercises, electrotherapy, vertebral traction, heat, cold.

Locations

Country	Name	City	State
France	FasciaFrance	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
FasciaFrance	University Fernando Pessoa

Country where clinical trial is conducted

France, 

References & Publications (9)

Boureau F. L'appréciation de la sévérité d'une douleur chronique. Médecine et hygiène. 1987;45(1703):1560-6.

Bruyere O, Demoulin M, Beaudart C, Hill JC, Maquet D, Genevay S, Mahieu G, Reginster JY, Crielaard JM, Demoulin C. Validity and reliability of the French version of the STarT Back screening tool for patients with low back pain. Spine (Phila Pa 1976). 2014 Jan 15;39(2):E123-8. doi: 10.1097/BRS.0000000000000062. — View Citation

Carlsson AM. Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain. 1983 May;16(1):87-101. doi: 10.1016/0304-3959(83)90088-X. — View Citation

Courraud C, Bois D, Lieutaud A. Apports de la pratique de la fasciathérapie à l'exercice de la physiothérapie: le point de vue des praticiens. Mains Libres. 2016;(3):49-58.

Lawlis GF, Cuencas R, Selby D, McCoy CE. The development of the Dallas Pain Questionnaire. An assessment of the impact of spinal pain on behavior. Spine (Phila Pa 1976). 1989 May;14(5):511-6. doi: 10.1097/00007632-198905000-00007. — View Citation

Leplege A, Ecosse E, Verdier A, Perneger TV. The French SF-36 Health Survey: translation, cultural adaptation and preliminary psychometric evaluation. J Clin Epidemiol. 1998 Nov;51(11):1013-23. doi: 10.1016/s0895-4356(98)00093-6. — View Citation

Marty M, Blotman F, Avouac B, Rozenberg S, Valat JP. Validation of the French version of the Dallas Pain Questionnaire in chronic low back pain patients. Rev Rhum Engl Ed. 1998 Feb;65(2):126-34. Erratum In: Rev Rhum Engl Ed 1998 May;65(5):363. — View Citation

Ware J, Kolinski M, Keller S. How to score the SF-12 physical and mental health summaries: a user's manual. Boston: The Health Institute, New England Medical Centre, Boston, MA. 1995;

Wilke J, Schleip R, Klingler W, Stecco C. The Lumbodorsal Fascia as a Potential Source of Low Back Pain: A Narrative Review. Biomed Res Int. 2017;2017:5349620. doi: 10.1155/2017/5349620. Epub 2017 May 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)	Before the 1st session (start of the study for the patient)
Primary	Pain intensity	Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)	After the 1st session (30 to 45 minutes after the previous measure)
Primary	Pain intensity	Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)	Before the 2nd session (within a total timeframe of 3 months)
Primary	Pain intensity	Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)	After the 2nd session (30 to 45 minutes after the previous measure)
Primary	Pain intensity	Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)	Before the 3rd session (within a total timeframe of 3 months)
Primary	Pain intensity	Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)	After the 3rd session (30 to 45 minutes after the previous measure)
Primary	Pain intensity	Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)	Before the 4th session (within a total timeframe of 3 months)
Primary	Pain intensity	Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)	After the 4th session (30 to 45 minutes after the previous measure)
Primary	Pain intensity	Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)	Before the 5th session (within a total timeframe of 3 months)
Primary	Pain intensity	Measure of pain intensity with Visual Analog Scale: 0 (no pain) to 10 (worst imaginable pain)	After the 5th session (30 to 45 minutes after the previous measure)
Secondary	Change in functional abilities	Evaluation of the functional disability change, with French version of Dallas Pain Questionnaire: 4 items evaluated from 0 (no impact) to 100% (maximun impact)	Before the 1st session and after the last (5st) session, in a timeframe of 3 months
Secondary	Change in the quality of life	Assessment of the change in the quality of life with the French version of the short version (SF-12) of "Short Form with 36 questions" (SF-36) questionnaire: scale from 0 (bad) to 100 (best)	Before the 1st session and after the last (5st) session, in a timeframe of 3 months
Secondary	Change in trait of anxiety	Evaluation of the change in trait of anxiety with State Trait Inventory Anxiety questionnaire, part Y-B: scale from 20 (no anxiety) to 80 (maximum anxiety)	Before the 1st session and after the last (5st) session, in a timeframe of 3 months
Secondary	Evaluation of state of anxiety	Evaluation of the change in state of anxiety with State Trait Inventory Anxiety questionnaire, part Y-A: scale from 20 (no anxiety) to 80 (maximum anxiety)	Before the 1st session (start of the study for the patient)
Secondary	Evaluation of state of anxiety	Evaluation of the change in state of anxiety with State Trait Inventory Anxiety questionnaire, part Y-A: scale from 20 (no anxiety) to 80 (maximum anxiety)	After the 1st session (30 to 45 minutes after the previous measure)
Secondary	Evaluation of state of anxiety	Evaluation of the change in state of anxiety with State Trait Inventory Anxiety questionnaire, part Y-A: scale from 20 (no anxiety) to 80 (maximum anxiety)	Before the 2nd session (within a total timeframe of 3 months)
Secondary	Evaluation of state of anxiety	Evaluation of the change in state of anxiety with State Trait Inventory Anxiety questionnaire, part Y-A: scale from 20 (no anxiety) to 80 (maximum anxiety)	After the 2nd session (30 to 45 minutes after the previous measure)
Secondary	Evaluation of state of anxiety	Evaluation of the change in state of anxiety with State Trait Inventory Anxiety questionnaire, part Y-A: scale from 20 (no anxiety) to 80 (maximum anxiety)	Before the 3rd session (within a total timeframe of 3 months)
Secondary	Evaluation of state of anxiety	Evaluation of the change in state of anxiety with State Trait Inventory Anxiety questionnaire, part Y-A: scale from 20 (no anxiety) to 80 (maximum anxiety)	After the 3rd session (30 to 45 minutes after the previous measure)
Secondary	Evaluation of state of anxiety	Evaluation of the change in state of anxiety with State Trait Inventory Anxiety questionnaire, part Y-A: scale from 20 (no anxiety) to 80 (maximum anxiety)	Before the 4th session (within a total timeframe of 3 months)
Secondary	Evaluation of state of anxiety	Evaluation of the change in state of anxiety with State Trait Inventory Anxiety questionnaire, part Y-A: scale from 20 (no anxiety) to 80 (maximum anxiety)	After the 4th session (30 to 45 minutes after the previous measure)
Secondary	Evaluation of state of anxiety	Evaluation of the change in state of anxiety with State Trait Inventory Anxiety questionnaire, part Y-A: scale from 20 (no anxiety) to 80 (maximum anxiety)	Before the 5th session (within a total timeframe of 3 months)
Secondary	Evaluation of state of anxiety	Evaluation of the change in state of anxiety with State Trait Inventory Anxiety questionnaire, part Y-A: scale from 20 (no anxiety) to 80 (maximum anxiety)	After the 5th session (30 to 45 minutes after the previous measure)
Secondary	Drug consumption	Evaluation of drug consumption (interview of the patient)	1st session (start of the study for the patient)
Secondary	Drug consumption	Evaluation of drug consumption (interview of the patient)	2nd session (within a total timeframe of 3 months)
Secondary	Drug consumption	Evaluation of drug consumption (interview of the patient)	3rd session (within a total timeframe of 3 months)
Secondary	Drug consumption	Evaluation of drug consumption (interview of the patient)	4th session (within a total timeframe of 3 months)
Secondary	Drug consumption	Evaluation of drug consumption (interview of the patient)	5th session (within a total timeframe of 3 months)

External Links

•   French Haute Autorité de Santé guidelines for the treatment of non-specific Low Back Pain